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Completed

NCT Number: NCT01251276

Hepatitis B Challenge Dose in Adults (V232-059-10)

The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In general good health based on a medical history.
  • Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Exclusion criteria

  • Known history of previous Hepatitis B infection.
  • History of vaccination with any Hepatitis B vaccine within the last 2 years.
  • History of febrile illness.
  • Known or suspected hypersensitivity to any component of HBVaxPro.
  • Receipt of medication / vaccine that may interfere with study assessments.
  • Known or suspected immune impairment.
  • Pregnant women and nursing mothers.

Treatment and study plan

Modified Process Hepatitis B Vaccine

Biological

Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study

Other names: HBVaxPro

Primary outcomes

  1. Percentage of Seroresponders Before and After the Challenge Vaccination

    Time frame: Predose (Day 1) and 1 month after challenge dose (Month 1)

    A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.

Secondary outcomes

  1. Percentage of Participants With One or More Adverse Experiences

    Time frame: Up to Day 15 after challenge dose

    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.

  2. Percentage of Participants Who Discontinued the Study Due to an Adverse Experience

    Time frame: Up to Month 7

    The percentage of participants who discontinued the study due to an adverse experience was assessed.

  3. Percentage of Participants With One or More Injection-site Adverse Experiences

    Time frame: Up to Day 15 after challenge dose

    The percentage of participants with one or more injection-site adverse experiences was assessed.

  4. Percentage of Participants With One or More Systemic Adverse Experiences

    Time frame: Up to Day 15 after challenge dose

    The percentage of participants with one or more systemic adverse experiences was assessed.

  5. Percentage of Participants With One or More Serious Adverse Experiences

    Time frame: Up to Month 1 after challenge dose

    A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 1, 2010
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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